1

2
OBJECTIVES

3
STRUCTURE
OF ICH
 The Steps in ICH Process

1 2 3 4 5

5
 Guidelines

QUALITY SAFETY

MULTI-
EFFICACY
DISCIPLINARY
QUALITY

7 7
8 8
9 9
10 10
11 11
SAFETY

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15
EFFICACY

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MULTIDISCIPLINARY

M1: Medical Terminology

It provides an international medical dictionary
applicable to all phase of Product Development.

M2: Electronic Standards for

Transmission of Regulatory
Information (ESTRI)
It facilitates international electronic
communication by evaluating and recommending
the specifications. 22
M3(R2): Guidance on Non-Clinical
Safety Studies for the Conduct of
Human Clinical Trials and
Marketing Authorization for
Pharmaceuticals

M4: The Common Technical

Document
It provides a harmonized structure for new product
applications

M5: Data Elements and Standards

for Drug Dictionaries

23
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